Long-term Extension to Miravirsen Study in Null Responder to Pegylated Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C

Hepatitis C Clinical Trial

Official title:

Long-term Extension to a Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Null Responders to Pegylated-Interferon Alpha Plus Ribavirin in Subjects With Chronic Hepatitis C (CHC) Virus Genotype 1 Infection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02031133
• Other study ID #: SPC3649-207E
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 7, 2014
• Last updated: November 17, 2014
• Start date: January 2014
• Est. completion date: January 2017

Study information

• Verified date: November 2014
• Source: Santaris Pharma A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

Study SPC3649-207E is designed as an extension study to the prior protocol to provide additional long-term safety and efficacy information for subjects participating in Study SPC3649-207.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• Participated in study SPC3649-207

Exclusion Criteria:

• Received investigational drug therapy after discontinuation, termination, or successful completion of study SPC3649-207

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Miravirsen

Locations

Country	Name	City	State
Puerto Rico	Fundacion de Investigation de Diego	San Juan

Sponsors (1)

Lead Sponsor	Collaborator
Santaris Pharma A/S

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Viral resistance analysis through end of study.	The miR-122 seed sites in HCV RNA from subjects following viral breakthrough or relapse will be subjected to genotypic sequence analysis.	36 months	No
Primary	Safety and tolerability will be assessed by evaluation of liver ultrasound, physical examinations, vital signs, and routine laboratory assessments (serum chemistry, hematology, coagulation, and urinalysis).		36 months	Yes
Secondary	Change in HCV RNA level from baseline through end of study.		36 months	No